Home Versus Office Biofeedback Training for Dyssynergic Defecation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Number of Complete Spontaneous Bowel Movements
研究概览
简要总结
Test the Efficacy of Home Biofeedback Training: Currently, biofeedback requires a skilled therapist and sophisticated equipment and is not widely available. The investigators designed and tested a novel home biofeedback device and predict that home training will be as effective as office biofeedback therapy. Our specific aims are to perform a randomized controlled trial of 100 subjects with dyssynergic defecation to investigate:
(A) Whether a self-administered, home-biofeedback training program with a new portable device is as effective as office-based biofeedback therapy in improving i) physiology- dyssynergia (defecation index), and ability to expel simulated stool, and ii) symptomatology- satisfaction with bowel function, number of complete spontaneous bowel movements, stool consistency, straining and quality of life.
(B) Whether home-training is more cost-effective than office-based biofeedback training.
详细描述
Study Protocol: Patients will be randomized to receive either office-based biofeedback therapy or home-based biofeedback training, in addition to the standard treatment described below.
Randomization procedures: The permuted blocks method will randomize patients for all study aims; this ensures approximate balance among the two treatment arms, while making it unlikely that investigators will predict the next treatment assignment. The study statistician will prepare sequentially numbered sealed envelopes containing the treatment assignment. Thus the next treatment assignment cannot be read without opening the envelope. If a patient is deemed eligible, and agrees to participate, after signing the informed consent, the investigator will open the next envelope to determine the treatment assigned to that patient.
Standard Treatment: The patient will be seen by one of the gastroenterologists and receive instructions regarding their problem and advice on exercises, timed toilet training, laxatives, diet and fluid intake. Written materials will be given to each patient and the study coordinator will reinforce the information.
Timed-toilet training: This consists of educating the patient regarding the anatomy and physiology of the pelvic floor and diaphragmatic breathing technique. They will be advised to attempt a bowel movement twice a day, 30 minutes after meals and strain for five minutes and push at a level of 5-7/10.
Laxatives: Patients will be asked to use 500 mg magnesium gluconate, 2-3 tablets/day or Milk of Magnesia 1-3 tablespoons daily. If intolerant, they will be advised to use bisacodyl (1-2 daily) or sennokot (1-2 daily), but to titrate the dose. Patients will be asked to refrain from using digital maneuvers and enemas. Rescue medications will include bisacodyl suppositories (no BM for 48 hrs) or enema (no BM for 72 hours). If bowel movement is regular i.e. soft stool >3/week, they will be asked to reduce the laxative dose by 1/3rd.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •During the previous year, all patients must have experienced or reported at least two of the following symptoms for at least three months and with 25% of bowel movements (when not taking laxatives):
- •stool frequency of less than three/week,
- •passage of hard stools,
- •excessive straining,
- •a feeling of incomplete evacuation,
- •sensation of anorectal obstruction or blockage and
- •use of manual maneuvers to facilitate defecations (e.g., digital evacuation).
- •No evidence of structural disease (excluded by colonoscopy/ b. enema and metabolic problem by lab tests.
- •Patients on stable doses of antidepressants without anticholinergic effects will be included.
排除标准
- •Patients taking drugs that are constipating, (e.g.; calcium channel antagonists will either be excluded or drug discontinued)
- •Patients with co-morbid illnesses; severe cardiac disease, chronic renal failure or previous gastrointestinal surgery except cholecystectomy and appendectomy.
- •Neurologic diseases e.g.; head injury, epilepsy, multiple sclerosis, strokes, spinal cord injuries.
- •Impaired cognizance (mini mental score of < 15) and/or legally blind.
- •Pregnant or likely to conceive during the course of the study. Women with potential for pregnancy must be willing to use contraceptive measures during the study. Urinary pregnancy tests will be performed on such women prior to any radiologic procedures.
- •Hirschsprung's disease.
- •Alternating constipation and diarrhea.
- •Ulcerative/Crohns colitis.
- •Previous pelvic surgery, rectocele/bladder repair, radical hysterectomy, anal surgery.
- •Rectal prolapse or anal fissure.
结局指标
主要结局
Number of Complete Spontaneous Bowel Movements
时间窗: 3 months
Number of how many bowel movements occur without using an aid to have a bowel movement.
Presence of Dyssynergia
时间窗: 3 months
Dyssynergia pattern
Balloon Expulsion Time
时间窗: 3 months
Time it takes for a subject to expel a balloon that has been inserted into the rectum.
Global Bowel Satisfaction
时间窗: 3 months
visual analog scale of symptoms
次要结局
- Colon Transit(3 months)